Further study details as provided by Jaslok Hospital and Research Centre:

Primary Outcome Measures:

Improvement in clinical condition of the patient assessed using UPDRS (UNIFIED PARKINSON'S DISEASE RATING SCALE) and Time Tests. [ Time Frame: Up to 18 months from the day of stem cell transplant. ] [ Designated as safety issue: Yes ]

Stem cell derived from the bone marrow of the patient will be stereotactically transplanted in the striatum.These stem cell are the expected to grow up into dopamine secreting neural cells.

Procedure: Autologous Bone marrow derived stem cells transplant

Stem cells are derived from the bone marrow of the patient and processed at Reliance life sciences.The stem cells are the stereotactically implanted in the striatum.

Other Names:

stem cells

cell therapy for Parkinson's disease

Detailed Description:

Parkinson's disease, a neurodegenerative disorder, still at its best can only be controlled by medical or surgical treatment. For more than two decades various groups have tried using modified cell transplants for curing this disease. Earlier results with use of fetal mesencephalic cell transplant were encouraging, but this had to be discontinued due to severe side effects.

Current interest, in the use of Mesenchymal stem cells as a pluripotent cell for developing neural cells has been the background for this study. Reliance Life sciences had found encouraging results with the use of human MSCs in Rat model of PD. Based on this and other data, Jaslok Hospital and Research Centre has initiated a pilot study to investigate the efficacy of Autologous MSCs in treating advanced PD. This cells will be harvested from bone marrow, processed at RLS laboratory and transplanted by stereotactic techniques into the striatum of the patient.

Eligibility

Ages Eligible for Study:

35 Years to 70 Years

Genders Eligible for Study:

Both

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria

Male or female between 35-70 years of age.

Patient with current diagnosis of PD with motor complications (as confirmed by neurologist) as per the standard criteria and guidelines.

Patients with at least 5 years since the disease.

Responsiveness to Levodopa or dopa agonist. This is defined as improvement between Off and On UPDRS by at least 33% of the Motor UPDRS.

PD of Stage 2.5, 3 & 4 of HOEHN & YAHR staging.

Stable Parkinsonian medications for the 60 days prior to the surgical therapy.

MRI not showing gross atrophy or any other pathology of brain.

Patients with score less than 19 for the Montgomery-Asberg Rating Scale (MADRS) for Depression.

NO Significant cognitive impairment.MMSE > 24.

The participant is able to comply with and understand the required visit schedule and all required tests and procedures.

The participant (and/or LAR) must sign an informed consent.

Exclusion Criteria:

History of intracranial surgeries or implantation of a device for Parkinson's disease two years prior to treatment.

History of psychiatric disorders like schizophrenia or psychotic disorders.

History of other malignancy, with the exception of treated cutaneous squamous cell or basal cell carcinoma, within 5 years.

Contraindication for MRI

General medical contraindications for surgery like coagulopathy

Subjects with abnormal hematology and chemistry values, unless the out of range values are clinically significant with respect to general surgery.

Severe skin infection or osteomyelitis at the site of bone marrow aspiration potentially limiting the procedure.

Positive test results for HIV.

History of drug or alcohol abuse

Pregnant or nursing women

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00976430

Locations

India

Jaslok Hospital And Research Centre

Mumbai, Maharashtra, India, 400026

Sponsors and Collaborators

Jaslok Hospital and Research Centre

Investigators

Principal Investigator:

Paresh k Doshi, MCh

Incharge Stereotactic and functional Neurosurgery,Jaslok Hospital and Research Centre.